QC Analyst

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

Reporting to the Manager, Analytical Chemistry, the Quality Control Analyst will execute QC testing in accordance with established Drug Product, API, and Raw Material Specifications; support protocol activities for method verifications and instrument qualifications; check, verify, and/or calibrate equipment; investigate and resolve or mitigate deviations, non-conformances, and OOS (Out of Specification) events associated with product tested at the POINT GMP facility.

Objectives

• Perform routine testing on Drug Products and Starting Materials utilizing chromatography methods (i.e., HPLC/UPLC, TLC, and GC), spectroscopy methods (i.e., Gamma Spectroscopy and FT-IR), and compendial wet chemistry testing, according to phase appropriate guidelines (ex. cGLP, cGMP).
• Support and execute method validation protocols associated with POINT drug products produced at the manufacturing facility and in accordance with applicable compendial (e.g., USP and EP) and ICH guidelines, as well as the established Quality Management System.
• Ensure all drug products are tested in accordance with highest standards of Good Manufacturing Practice (GMP), ICH guidelines, and according to regulatory guidelines, laws, and Standard Operating Procedures (SOPs).

Accountabilities

• Conduct chemical and physical testing of raw materials, API, in-process and radioactive finished products, using established test methods to provide accurate and reliable data to ensure their strength, identity and purity.
• Work with radioactive materials using safe protocols to maintain ALARA principles.
• Maintaining accurate and complete lab data documentation as per cGLP and/or cGMP, as appropriate.
• Recording and reporting results of analysis in accordance with approved lab procedures, standard test methods, and systems.
• Participating and contributing to the maintenance and calibration of analytical instruments within the quality control laboratories.
• Collaborating with other departments (QA, CMC, Manufacturing, etc.) on studies, investigations, and problem-solving.
• Adhering to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
• Working well in a fast-paced team environment.
• Performing other duties as assigned.

Requirements

Education and Experience:

• BS or BA in STEM with a minimum of one year of relevant industry experience in analytical laboratories.
• Alternatively, applicants will also be considered who have the following: 4 to 6 years of GMP Pharma experience in a Production or Lab role that required attention to detail, thorough documentation, and consistent technique in solution preparations.
• Experience working with radiopharmaceuticals will be considered an asset but is not a requirement
• Experience working in a pharmaceutical GMP manufacturing environment is preferred
• The position will start at typical business hours, Monday thru Friday during start-up, commissioning, and qualification of the facility and operations. Some evening or weekend work may be required on a minimum basis.

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of